NCT06557291Completed
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma
Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy After Relapse on Adjuvant Checkpoint Inhibitor Therapy and Subsequent Surgical Resection in Patients With BRAF V600-mutated Stage III/IV Melanoma
Source: ClinicalTrials.gov · Last updated 16 Aug 2024
Brief summary (registry, in English)
This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 38 (actual)
- First submitted
- 13 Aug 2024
- Start date
- 4 Oct 2022
- Primary completion date
- 16 Nov 2023
- Lead sponsor
- Novartis
- Diseases
- Melanoma
- NCT number
- NCT06557291
What you commit to
- Study type: Observational
- Participants enrolled: 38
- From 4 Oct 2022 to the primary completion date, 16 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies.
- More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy.
- Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.
Who the study is looking for
- Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma.
- Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis.
- Documented local or central assay-positive for tumor BRAF V600E/K mutation.
- Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy.
- Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection.
- Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Pharmaceuticals Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.